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Kelly Government Solutions

Clinical Protocol Coordinator - NIH - Bethesda, MD

Post Date:Jun 13, 2018Type:Full-Time
Start Date:6/13/2018Salary:
Location:US-MD-Bethesda Job Reference:US3191RS_BH1449008
Skills:
 

Job Description:

Clinical Protocol Coordinator - NIH- Bethesda, MD
TASKS/SERVICES.  The contractor shall:




  • Provide regulatory guidance and assistance for protocol development, implementation, continuing support for NIDDK intramural research protocols.

  • Serve as the point-of-contact and project manager for an assigned portfolio of projects.

  • Work with PIs and the research team on the design, plan, production and revision of study documents, including applying clinical and regulatory knowledge to the review of protocol and informed consent documents.

  • Work with research staff to navigate requirements for protocol approval and continued conduct: complete submissions to approving bodies (e.g., scientific review, IRB and radiation safety), coordinate with PIs and the research team to ensure stipulations are addressed appropriately and on-time; track the required approvals necessary to initiate and continue intramural research.

  • Prepare program actions that do not go to the IRB such as data sharing plans, reliance agreements and technology transfer agreements.

  • Orchestrate meetings with Principal Investigators (PIs) and other key research staff to manage protocol start-up and continuation logistics.

  • Provide advice and assistance in troubleshooting human subjects protection issues.

  • Work with the Institutional Review Board (IRB) to keep abreast of new guidance related to protocol and informed consent submissions for both initial reviews and amendments, and to share relevant information with Protocol Navigation (PN) and research team members.




  • Work with the Office of Human Subjects Research Protection (OHSRP) to keep abreast of new guidance related to policy governing the conduct of research at the NIH Intramural Research Program, and to share relevant information with PN and research team members.

  • Collaborate and communicate with other divisions and individuals (Regulatory Affairs, the Clinical Safety Office and site monitors) to identify the regulatory guidelines and required timelines for Food and Drug Administration (FDA) requisite activities; ensure protocol design safety issues are identified early; ensure required oversight is initiated as outlined in the protocol.

  • Educate research staff regarding relevant aspects of regulatory process including requirements of protocol development, conduct of research trials, regulatory change, IRB and FDA submission requirements, radiation safety requirements, ethics clearances, and technology transfer.

  • Maintain regulatory files.

  • Participate in NIDDK’s Quality Assurance Program, including site initiation visits and periodic protocol monitoring.

  • Identify and make recommendations to improve the processes, procedures and policies of the Office and assist in issuing guidance.

  • Disseminate expertise and best practices related to Human Protections in clinical re-search through presentations, publications, and/or interactions with colleagues.

  • Attend meetings of various HRPP groups within NIH, including HSRAC, IPAC, etc.



 
DELIVERABLES.  Upon request, the contractor shall provide documentation evidence of any and/or all work product, including, but not limited to, the following tasks:
 




  • Work products and documents related to providing regulatory guidance and assistance for protocol development, implementation, continuing support for NIDDK intramural research protocols; serve as the point-of-contact and project manager for an assigned portfolio of projects.

  • Work products and documents related to the design, plan, production and revision of study documents; navigate requirements for protocol approval and continued conduct: complete submissions to approving bodies; track the required approvals necessary to initiate and continue intramural research.

  • Work products and documents related to data sharing plans, reliance agreements and technology transfer agreements; troubleshoot human subjects protection issues; keep abreast of new guidance related to protocol and informed consent submissions.

  • Work products and documents related to identifying the regulatory guidelines and required timelines for FDA requisite activities; educate research staff regarding relevant aspects of regulatory process including requirements; maintain regulatory files.

  • Work products and documents related to site initiation visits and periodic protocol monitoring; identify and make recommendations to improve the processes, procedures and policies; disseminate expertise and best practices related to Human Protections in clinical re-search; attend meetings of various HRPP groups within NIH.



 
CERTIFICATIONS, LICENSE, PHYSICAL REQUIREMENTS OR OTHER EXPERTISE REQUIRED.  The contractor must have:
 




  • Master’s degree in a life science or healthcare discipline; two (2) years of specialized experience plus a Bachelor’s degree is equivalent to a Master’s degree.

  • Minimum of three (3) years of experience managing IRB submissions.

  • Mastery of a wide range of scientific research concepts, principles, methods and techniques common to several recognized professional fields in the health, medical or allied sciences to serve as an expert and program authority to Principal Investigators and other staff responsible for approving protocols;

  • Mastery of the IRB process concepts, methods and techniques;

  • Mastery of advanced management and organizational principles and practices to plan, implement and track complex clinical research protocols encompassing a broad range of medical specialties conducted in numerous Institutes;

  • Ability to work in a clinical research regulatory setting, both independently and with a team, to coordinate, negotiate and facilitate program goals, mitigate potential problems, move projects forward expeditiously, and meet deadlines;

  • Ability to interact with a broad range of senior scientific, medical and management staff, expert advisors, and representatives of other Federal and non- Federal organizations; and

  • Expert knowledge of the NIH organization mission, structure, scientific policies and functions to design, coordinate and oversee complex special assignments of a sensitive or confidential nature.

  • Strong communications skills, both oral and written.

  • Excellent interpersonal, analytical, organizational and time management skills.





About Kelly Services®


As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.





Contact Information
Kelly Government Solutions
Name: Tananda Arenas-Bertol


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